Status:
COMPLETED
The FEIBA NovoSeven Comparative Study
Lead Sponsor:
Skane University Hospital
Conditions:
Severe Hemophilia A With an Inhibitor
Eligibility:
MALE
2+ years
Phase:
NA
Brief Summary
FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of...
Detailed Description
The incidence of inhibitors among people with severe hemophilia A has been documented as approximately 20-30% in several prospective studies. In such patients acute hemorrhages frequently occur and pr...
Eligibility Criteria
Inclusion
- Congenital hemophilia A with an inhibitor and the need for by-passing agents in the case of joint bleeding.
- An expected bleeding frequency of \>=3 joint bleeds per year.
- Informed consent given.
- Age of two or older.
Exclusion
- Other congenital and acquired bleeding disorders.
- Symptomatic liver disease.
- Life expectancy \<12 months.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00166309
Start Date
July 1 2000
End Date
June 1 2005
Last Update
April 19 2007
Active Locations (1)
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1
Malmo University Hospital
Malmo, Sweden, SE-205 02